WHO DRUG INFORMATION VOLUME 13 - NUMBER 2 1999 PROPOSED INN LIST 81 INTERNATIONAL NONPROPRIETARY NAMES FOR PHARMACEUTICAL SUBSTANCES WORLD HEALTH ORGANIZATION • GENEVA WHO Drug Information Vol. 13, No. 2, 1999 General Policy Issues WHO roundtable with the International Generic Pharmaceutical Alliance On 11 February 1999, Dr Gro Harlem Brundtland, the Director-General of WHO, met with some key figures of the generic pharmaceutical industry to explore ways in which access to affordable, innova- tive and essential drugs can be improved. The roundtable was attended by the Chief-Executive Offic- ers of the principal generic pharmaceutical companies, the Chairman of the European Generic Medi- cines Association, and the co-Director of the International Generic Pharmaceutical Alliance (IGPA) The meeting offered an opportunity for both sides to address issues of public health concern including the WHO essential drugs concept, intellectual property issues and ensuring quality control and developing good manufacturing practice within the generics industry. WHO's goal is to build a constructive dialogue with the private sector and collaborate in improving global health. Global partnerships for health and perceptions. Some months ago, I met with representatives of the research-based industry and Gro Harlem Brundtland today I look forward to listening to the views and Director-General perceptions of the generic industry. World Health Organization WHO is one organization, with one policy and one We have been awaiting the opportunity to bring objective in the area of pharmaceuticals: to improve together leading representatives of the generic equity of access to essential drugs of assured pharmaceutical industry, and I am glad to see that quality as part of the fundamental right to health so many people with experience and insight have care. Equity is a core value. We need to constantly accepted our invitation to attend the roundtable. pursue strategies aimed at helping all people to access health services. A roundtable, as we apply the term in WHO, is not a single event. It is a method of work. The reason is We are committed to helping countries establish simple. There are many key players in world health, and sustain national drug policies, as we are com- and those key players need to meet and talk. They mitted to the concept of essential drugs and vac- need to exchange views, look for common ground cines, and the establishment of norms and stand- and be aware of differences. WHO invites its part- ards to obtain quality drugs for patients. ners in health whether from among the UN family, industry, or nongovernmental organizations to join The Essential Drugs and Other Medicines Depart- in a dialogue on the key issues facing us. ment is WHO's main instrument in helping govern- ments to implement these policies and to promote Pharmaceuticals, of course, are critical to any the essential drugs concept. Essential drugs are health system. In some parts of the world access to one of the most cost-effective elements in modern drugs and vaccines is almost routine. But we have health care, and their potential health impact is seen negative consequences on populations who crucial. are denied access even to the most essential drugs. Our objective is to define a clear, transpar- This year alone, there will be over 40 million deaths ent and unified policy to guide the WHO clusters, in developing countries, one-third among children departments and regions in their contacts and under five. Ten million deaths will be due to acute relations with the pharmaceutical industry. respiratory infections, diarrhoeal diseases, tubercu- losis, and malaria — all are conditions for which The pharmaceutical industry is not a single body — safe, inexpensive, essential drugs of assured different sectors of this industry have different views quality can be life-saving. 61 General Policy Issues WHO Drug Information Vol. 13, No. 2, 1999 Simple folic acid + ferrous salt preparations can governments, industry, and other partners to en- reduce maternal and infant mortality arising from courage legislation and regulation which supports anaemia during pregnancy; treatment of sexually- improved access to essential drugs. This includes, transmitted diseases can reduce transmission of of course, access to generic drugs of assured HIV; and treatment of hypertension reduces heart quality. attacks and strokes. WHO has done important work in the area of ge- The economic impact of pharmaceuticals is also neric drugs. Earlier this week we had a consultation substantial — especially in developing countries. on "Global comparator drug products for multi- While spending on pharmaceuticals represents less source bioequivalence testing". This is one of than one-fifth of total public and private health several initiatives aimed at making generic drugs of spending in most developed countries, it represents assured quality more available. 15–30% of total health spending in transitional economies and 25–66% in developing countries. In We need contributions from both the generic as most low-income countries, pharmaceuticals ac- well as the research-based pharmaceutical industry count for the largest public health expenditure after and we need to create the right incentives for personnel, and the largest household health ex- innovation. There have to be constructive ways of penditure. recovering investments in research and develop- ment. But generally we need to look for the most Furthermore, lack of essential drugs, irrational use cost-effective solutions, those which guarantee the of drugs, and poor drug quality remain a serious users quality drugs at an acceptable price. global health problem. Let me mention some exam- ples: WHO remains committed to national drug policies as part of national health policies. The national drug • Over one-third of the world's population still lacks policy process can and should engage the public access to essential drugs. sector, professional bodies, the private sector, consumers, academics, and other concerned • In the poorest parts of Africa and Asia, this partners. In this way, we can work together to number climbs to over 50%. develop new strategies for addressing the problem of drug access. We need to support an environment • 50–90% of drugs purchased in developing coun- which allows quality production of drugs to take tries are paid for out-of-pocket. place also in developing countries. • The burden falls mainly on the poor who are not This roundtable is a point of departure. I am certain adequately protected by health policies. that we will find sufficient common ground for a genuine partnership in the future to address critical • Up to 75% of antibiotics are prescribed inappropri- issues in the area of access to essential drugs. ately. • Antimicrobial resistance is growing for most major Role of the international generic infectious diseases. pharmaceutical industry • Worldwide, an average of only 50% of patients in public health take their medicines correctly. G. Perry, International Generic • 10–20% of sampled drugs fail quality control tests Pharmaceutical Alliance, Brussels, Belgium in many developing countries. The decision to have a roundtable discussion with A lot remains to be done. National policies and representatives of the generic pharmaceutical procedures can be improved. We need mecha- industry is an important recognition by WHO that nisms which ensure that quality-controlled drugs there are many players on the pharmaceutical are made more available to all at the lowest possi- scene. Although in commercial terms globalization ble price. We know that generic drugs are usually of the generic industry is less than ten years old, it more affordable, and here your activities can com- has only recently acted at global level as an asso- plement our goals. WHO is currently working with ciation. 62 WHO Drug Information Vol. 13, No. 2, 1999 General Policy Issues The existence of the International Generic Pharma- in place that will prevent the production and trade in ceutical Alliance (IGPA) owes much to WHO. The counterfeit versions of generic medicines. Organization has encouraged our companies and regional associations to join together at interna- Thirdly, what measures are needed to develop and tional level. WHO was also extremely helpful in promote a market based on generics? WHO has ensuring IGPA participation in the International laid the foundations for this in its "enabling meas- Conference on Harmonization (ICH) process. ures" outlined in its document Public–Private Roles During our short existence, the IGPA has already in the Pharmaceutical Sector: Implications for participated in WHO working groups dealing with Equitable Access and Rational Drug Use (1). WHO bioequivalence, registration and issues of counter- has also acknowledged the implications of Trade feiting. Related Aspects of Intellectual Property Rights (TRIPS) to world health and we fully support the WHO has stated that generic medicines are critical decision by WHO to produce its report Globalization for ensuring access to pharmaceutical care and has and Access to Drugs: Perspectives on the WTO/ played a significant role in the promotion of generic TRIPS Agreement (2). We wish to stress the impor- medicines through its essential drugs policy. How- tance that a balanced intellectual property law will ever, affordability is only one aspect of generic give to the future of any programme for generics medicine use. We must stress that off-patent medi- and to WHO's essential drugs policy. Critical to this cines can only be classed as generic if they meet is the need for generic manufacturers to undertake all the required standards of safety, efficacy and the preparatory work necessary to produce a quality. We understand that WHO is also sensitive generic product during the patent period of the to this point. originator product. In our view, generic medicines offer the following In many areas, we see our objectives overlapping advantages to health systems. with those of WHO. Indeed, IGPA's main objective is to ensure that all consumers have access to • Good quality therapy which is less expensive.